Brainlab AG
9 AI-enabled device listings under this company name on the FDA list. The name is copied as published. It is not a review of the company.
| Date | Submission | Device | Panel | Code |
|---|---|---|---|---|
| June 17, 2025 | K250440 | RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT | Radiology | MUJ |
| June 13, 2025 | K243633 | Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) | Radiology | QIH |
| March 20, 2024 | K234047 | Automatic Registration | Neurology | OLO |
| September 9, 2023 | K223864 | Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial | Neurology | HAW |
| August 2, 2023 | K223553 | Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine | Neurology | OLO |
| July 21, 2023 | K223288 | Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI | Neurology | HAW |
| July 14, 2023 | K223106 | Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0) | Radiology | QIH |
| April 27, 2023 | K223734 | ENT EM | Neurology | PGW |
| April 19, 2023 | K223552 | Brainlab Elements Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial | Neurology | HAW |